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Daptomycin In Sodium Chloride

FDA Drug Information • Also known as: Daptomycin In Sodium Chloride

Brand Names
Daptomycin In Sodium Chloride
Drug Class
Lipopeptide Antibacterial [EPC]
Route
INTRAVENOUS
Dosage Form
INJECTION, SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Daptomycin in Sodium Chloride Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus . The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ℇ1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin in Sodium Chloride Injection is a single-dose frozen, premixed, iso-osmotic, sterile, nonpyrogenic solution containing either 350 milligrams or 500 milligrams of daptomycin, per 50 mL GALAXY container (PL 2040 Plastic); or 700 milligrams or 1,000 milligrams daptomycin, per 100 mL GALAXY container (PL 2040 Plastic). Daptomycin in Sodium Chloride Injection must be a clear, slightly yellow solution. Sodium Chloride, USP (0.9%) has been added to adjust osmolality. The approximate osmolality is 320 mOsmol/kg. Monobasic Sodium Phosphate, USP and Dibasic Sodium Phosphate, USP were added as buffer agents and the pH may have been adjusted with Hydrochloric Acid, NF and/or Sodium Hydroxide, NF. Water for Injection, USP is added as drug vehicle. Contains no preservative. The solution is intended for intravenous use after thawing to room temperature. This GALAXY container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Daptomycin in 0.9% Sodium Chloride Structual Formula

What Is Daptomycin In Sodium Chloride Used For?

1 INDICATIONS AND USAGE Daptomycin in Sodium Chloride Injection is a lipopeptide antibacterial indicated for the treatment of:

  • Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved ( 1.1 ) and,
  • Staphylococcus aureus bloodstream infections (bacteremia), in adult patients for whom appropriate dosing can be achieved, including those with right-sided infective endocarditis, ( 1.2 )
  • Staphylococcus aureus bloodstream infections (bacteremia) in pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved. ( 1.3 ) Limitations of Use
  • Daptomycin in Sodium Chloride Injection is not indicated for the treatment of pneumonia. ( 1.4 )
  • Daptomycin in Sodium Chloride Injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. ( 1.4 )
  • Daptomycin in Sodium Chloride Injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs. ( 1.4 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin in Sodium Chloride Injection and other antibacterial drugs, Daptomycin in Sodium Chloride Injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 Complicated Skin and Skin Structure Infections (cSSSI) Daptomycin in Sodium Chloride Injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved, with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only). 1.2 Staphylococcus aureus Bloodstream Infections (Bacteremia) in Adult Patients, Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates Daptomycin in Sodium Chloride Injection is indicated for the treatment of adult patients for whom appropriate dosing can be achieved, with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. 1.3 Staphylococcus aureus Bloodstream Infections (Bacteremia) in Pediatric Patients (1 to 17 Years of Age) Daptomycin in Sodium Chloride Injection is indicated for the treatment of pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved with Staphylococcus aureus bloodstream infections (bacteremia). 1.4 Limitations of Use Daptomycin in Sodium...

    • Dosage and Administration

    2 DOSAGE AND ADMINISTRATION If a dose of Daptomycin in Sodium Chloride Injection is required that does not equal 350 mg, 500 mg, 700 mg or 1,000 mg, this product is not recommended for use and an alternative formulation of daptomycin should be considered. ( 2.1 ) Adult Patients

  • Administer to adult patients intravenously by infusion over a 30-minute period. ( 2.1 , 2.7 )
  • Recommended dosage regimen for adult patients ( 2.2 , 2.4 , 2.6 ): Creatinine Clearance (CL CR ) Dosage Regimen cSSSI For 7 to 14 days S. aureus Bacteremia For 2 to 6 weeks ≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours <30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours* *Administered following hemodialysis on hemodialysis days. Pediatric Patients
  • Administer to pediatric patients intravenously by infusion over a 30- or 60-minute period, based on age. ( 2.1 , 2.7 )
  • Recommended dosage regimen for pediatric patients (1 to 17 years of age) with cSSSI, based on age ( 2.3 ): Age group Dosage* Duration of therapy 12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days 7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes 2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes 1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established.
  • Recommended dosage regimen for pediatric patients (1 to 17 years of age) with S. aureus bacteremia, based on age ( 2.5 ): Age group Dosage* Duration of therapy 12 to 17 years 7 mg/kg once every 24 hours infused over 30 minutes Up to 42 days 7 to 11 years 9 mg/kg once every 24 hours infused over 30 minutes 1 to 6 years 12 mg/kg once every 24 hours infused over 60 minutes *Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established. 2.1 Important Administration Duration Instructions If a dose of Daptomycin in Sodium Chloride Injection is required that does not equal 350 mg, 500 mg, 700 mg or 1,000 mg, this product is not recommended for use and an alternative formulation of daptomycin should be considered. Adult Patients: Administer the appropriate dose of Daptomycin in Sodium Chloride Injection to adult patients by intravenous infusion over a thirty (30) minute period [see Dosage and Administration (2.2 , 2.4 , 2.7) ] . Pedatric Patients (1 to 17 Years of Age)
  • Pediatric Patients 7 to 17 years of Age: Administer Daptomycin in Sodium Chloride Injection intravenously by infusion over a 30-minute period [see Dosage and Administration (2.3 , 2.5 , 2.7) ].
  • Pediatric Patients 1 to 6 years of Age: Administer Daptomycin in Sodium Chloride Injection intravenously by infusion over a 60-minute period [see Dosage and...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Anaphylaxis/Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]
  • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.2) ]
  • Eosinophilic Pneumonia [see Warnings and Precautions (5.3) ]
  • Drug Reaction with Eosinophilia and Systemic Symptoms [see Warnings and Precautions (5.4) ]
  • Tubulointerstitial Nephritis [see Warnings and Precautions (5.5) ]
  • Peripheral Neuropathy [see Warnings and Precautions (5.6) ]
  • Increased International Normalized Ratio (INR)/Prolonged Prothrombin Time [see Warnings and Precautions (5.11) and Drug Interactions (7.2) ]
  • Adult cSSSI Patients: The most common adverse reactions that occurred in ≥2% of adult cSSSI patients receiving daptomycin for injection 4 mg/kg were diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated creatine phosphokinase (CPK), urinary tract infections, hypotension, and dyspnea. (6.1)
  • Pediatric cSSSI Patients: The most common adverse reactions that occurred in ≥2% of pediatric patients receiving daptomycin for injection were diarrhea, vomiting, abdominal pain, pruritus, pyrexia, elevated CPK, and headache. (6.1)
  • Adult S. aureus bacteremia/endocarditis Patients: The most common adverse reactions that occurred in ≥5% of S. aureus bacteremia/endocarditis patients receiving daptomycin for injection 6 mg/kg were sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritus, increased sweating, insomnia, elevated CPK, and hypertension. (6.1)
  • Pediatric S. aureus bacteremia Patients: The most common adverse reactions that occurred in ≥5% of pediatric patients receiving daptomycin for injection were vomiting and elevated CPK. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Adult Patients Clinical trials enrolled 1,864 adult patients treated with daptomycin for injection and 1,416 treated with comparator. Complicated Skin and Skin Structure Infection Trials in Adults In Phase 3 complicated skin and skin structure infection (cSSSI) trials in adult patients, daptomycin for injection was discontinued in 15/534 (2.8%) patients due to an adverse reaction, while comparator was discontinued in 17/558 (3.0%) patients. The rates of the most common adverse reactions, organized by body system, observed in adult patients with cSSSI (receiving 4 mg/kg daptomycin for injection) are displayed in Table 6 . Table 6. Incidence of Adverse Reactions that Occurred in ≥2% of Adult Patients in the Daptomycin for Injection Treatment Group and ≥ the Comparator Treatment Group in Phase 3 cSSSI Trials Adverse Reaction Adult Patients (%) Daptomycin for Injection 4 mg/kg (N=534) Comparator Comparator: vancomycin (1 g IV every 12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses). (N=558) Gastrointestinal disorders Diarrhea 5.2 4.3 Nervous system disorders Headache 5.4 5.4 Dizziness 2.2 2.0 Skin/subcutaneous disorders Rash 4.3 3.8 Diagnostic investigations Abnormal liver function tests 3.0 1.6 Elevated CPK 2.8 1.8 Infections Urinary tract infections 2.4 0.5 Vascular disorders Hypotension 2.4 1.4 Respiratory disorders Dyspnea 2.1 1.6 Drug-related adverse reactions (possibly or probably drug-related) that occurred in <1% of adult patients receiving daptomycin for injection in the cSSSI trials are as follows: Body as a Whole: fatigue, weakness, rigors, flushing, hypersensitivity Blood/Lymphatic System:...

    • Drug Interactions

    7 DRUG INTERACTIONS 7.1 HMG-CoA Reductase Inhibitors In healthy adult subjects, concomitant administration of daptomycin for injection and simvastatin had no effect on plasma trough concentrations of simvastatin, and there were no reports of skeletal myopathy [see Clinical Pharmacology (12.3) ]. However, inhibitors of HMG-CoA reductase may cause myopathy, which is manifested as muscle pain or weakness associated with elevated levels of creatine phosphokinase (CPK). In the adult Phase 3 S. aureus bacteremia/endocarditis trial, some patients who received prior or concomitant treatment with an HMG-CoA reductase inhibitor developed elevated CPK [see Adverse Reactions (6.1) ]. Experience with the coadministration of HMG-CoA reductase inhibitors and daptomycin for injection in patients is limited; therefore, consideration should be given to suspending use of HMG-CoA reductase inhibitors temporarily in patients receiving Daptomycin in Sodium Chloride Injection. 7.2 Drug-Laboratory Test Interactions Clinically relevant plasma concentrations of daptomycin have been observed to cause a significant concentration-dependent false prolongation of prothrombin time (PT) and elevation of International Normalized Ratio (INR) when certain recombinant thromboplastin reagents are utilized for the assay. The possibility of an erroneously elevated PT/INR result due to interaction with a recombinant thromboplastin reagent may be minimized by drawing specimens for PT or INR testing near the time of trough plasma concentrations of daptomycin. However, sufficient daptomycin concentrations may be present at trough to cause interaction. If confronted with an abnormally high PT/INR result in a patient being treated with Daptomycin in Sodium Chloride Injection, it is recommended that clinicians: 1. Repeat the assessment of PT/INR, requesting that the specimen be drawn just prior to the next Daptomycin in Sodium Chloride Injection dose (i.e., at trough concentration). If the PT/INR value obtained at trough remains substantially elevated above what would otherwise be expected, consider evaluating PT/INR utilizing an alternative method. 2. Evaluate for other causes of abnormally elevated PT/INR results.

    Contraindications

    4 CONTRAINDICATIONS Daptomycin in Sodium Chloride Injection is contraindicated in patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1) ].

  • Known hypersensitivity to daptomycin (4)

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary Limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. Maternal body weight gain was decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area). In pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area). In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the...

    Overdosage

    10 OVERDOSAGE In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Daptomycin is cleared slowly from the body by hemodialysis (approximately 15% of the administered dose is removed over 4 hours) and by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours). The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with that removed by low-flux membranes.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Daptomycin in Sodium Chloride Injection is supplied as a single-dose premixed frozen isosmotic sterile, nonpyrogenic solution in 50 mL or 100 mL GALAXY plastic containers as follows: Code Product Description NDC Number 2G3593 350 milligrams daptomycin in 50 mL (7 mg/mL) Supplied as 24 bags per carton 0338-0712-24 2G3594 500 milligrams daptomycin in 50 mL (10 mg/mL) Supplied as 24 bags per carton 0338-0714-24 2G3595 700 milligrams daptomycin in 100 mL (7 mg/mL) Supplied as 12 bags per carton 0338-0716-12 2G3596 1,000 milligrams daptomycin in 100 mL (10 mg/mL) Supplied as 12 bags per carton 0338-0718-12 Store in a freezer capable of maintaining a temperature of -20°C (-4°F) or below [see Dosage and Administration (2.7) ] . Handle frozen product containers with care. Product containers may be fragile in the frozen state

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.